Peptisolv IV Special Precautions

In case any alarming symptom occurs (e.g., significant unintentional weight loss, recurrent vomiting, difficulty in swallowing, melena or hematemesis etc.) or when a gastric ulcer is diagnosed or suspected, treatment should not be initiated before malignancy is excluded, since treatment may delay diagnosis by symptom relief.
Co-administration of omeprazole with atazanavir is not recommended. If combination of atazanavir with proton pump inhibitors is inevitable, close clinical monitoring (e.g. virus load) for combinations with 100 mg of ritonavir and up to 400 mg doses of atazanavir is recommended while omeprazole dose should not exceed 20 mg.
Omeprazole, like all acid blocking agents, can reduce vitamin B12 (cyanocobalamin) absorption due to hypo- or achlorhydria. This should be considered in patients with limited body stores or risk factors due to reduced vitamin B12 absorption during long-term treatment. Omeprazole is a CYP2C19 inhibitor. Potential interactions with drugs that metabolize through CYP2C19 should be considered on initiating or ending treatment with omeprazole. An interaction between clopidogrel and omeprazole has been observed. Clinical significance of this interaction is not clear.
As a precaution, concomitant use of omeprazole and clopidogrel should be avoided.
Treatment with proton pump inhibitors may slightly increase the risk of gastrointestinal infections such as Salmonella and Campylobacter.
Bone fractures: Reports from various observational studies suggest that treatment with proton pump inhibitors (PPI) is associated with increased risk of hip, wrist or spine fractures as a result of osteoporosis. Risk of fractures is increased in patients on high doses, described as taking multiple daily doses or prolonged PPI treatment (one year or longer). Patients should receive PPI treatment at the lowest adequate dose for the minimum duration.
Hypomagnesemia: Symptomatic or asymptomatic hypomagnesemia has been rarely reported in patients treated with a PPI for at least 3 months and in most cases for one year. Serious adverse events include tetany, arrhythmias and convulsions. Management of hypomagnesemia requires magnesium replacement and discontinuation of PPI treatment in the majority of cases. For patients expected to receive prolonged treatment or those taking PPIs concomitantly with digoxin or drugs that may cause hypomagnesemia (e.g. diuretics), healthcare professionals might monitor magnesium levels before initiating PPI treatment and during follow-up.
Interference with tests for neuroendocrine tumors: Serum chromogranin A (CgA) levels increase secondary to drug-related reductions in gastric acid levels. Increased CgA levels may cause false positive results in diagnostic tests for neuroendocrine tumors. PPI treatment should be temporarily stopped before CgA level evaluation, and tests should be repeated if baseline CgA levels are high. If serial tests are performed (e.g., for monitoring), tests should be performed at the same laboratory to avoid reference range variations.
Particularly, patients treated for longer than one year should be regularly monitored.
This medicinal product contains less than 1 mmol (23 mg) of sodium per dose; thus, it is essentially "sodium free".
Effects on the ability to drive and use of machines: Omeprazole does not affect the ability to drive and use machines. Adverse drug reactions, including dizziness and visual impairment, may occur. Affected patients should not drive or use machines.